MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Fatigue (1849); Unspecified Infection (1930); Nausea (1970); Dizziness (2194); Neck Pain (2433); Polydipsia (2604)

Event Date 02/10/2020

Event Type  Injury  

Event Description

I began invisalign on (b)(6) 2020 and noticed dry mouth, sores in the mouth and on the tongue within the first week of use.I thought this was normal since i never had used the product before.When i started my second set of trays on (b)(6) 2020, that is when i started experiencing severe sinus pain on my right side, severe dizziness that sent me to urgent care (they put me on anti-biotics thinking it was a sinus infection because i had barotrauma to left ear.But the dizziness, nausea, hot and cold chills with no fever, dry cough, stomach pain, difficulty swallowing or feeling like i constantly have something stuck in my throat and serious fatigue were still present.I also had no appetite and have gas and burping whenever i drink liquids of any kind.I decided on (b)(6) 2020 to go to the er because my stomach pain moved to my right side and would enflame after eating.They did several blood tests and ultrasound of the affected area and they said it all looked normal and sent me home.So later that night i decided to take the trays out since that is the only thing that had changed in my life since i got so ill.Within 30 minutes of taking them out my sinus pressure and pain went away and so did the severe neck pain.Over the last several days i have slowly started to feel better, but a lot of my symptoms are still present.The safety data sheet on the aligners provided to me by my orthodontist doesn¿t show the composition of the aligners.He tried getting more information but all he was given was that they are made of thermoplastic polyurethane, bpa free, latex free and washed ionized water after manufacturing.I am also experiencing difficulty sleeping as i wake up several times in the night and have to swallow.I can¿t stay in a rem sleep due to whatever it is i¿ve been exposed to.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9775132
• MDR Text Key: 181772267
• Report Number: MW5093425
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 59